US20110022176A1 - Intervertebral body fusion cage with keels and implantation methods - Google Patents
Intervertebral body fusion cage with keels and implantation methods Download PDFInfo
- Publication number
- US20110022176A1 US20110022176A1 US12/924,741 US92474110A US2011022176A1 US 20110022176 A1 US20110022176 A1 US 20110022176A1 US 92474110 A US92474110 A US 92474110A US 2011022176 A1 US2011022176 A1 US 2011022176A1
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- implant
- anterior
- posterior
- keels
- superior
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
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- Prostheses (AREA)
Abstract
An intervertebral implant has a fusion body with at least one keel that anchors the implant into cancellous bone of at least one vertebral body. A method for implantation includes lateral implantation of the implant.
Description
- U.S. Provisional Patent Application No. 60/537,382 entitled INTEVERTEBRAL BODY FUSION CAGE WITH KEELS AND LATERAL IMPLANTATION METHOD, by Zucherman et al., filed Jan. 16, 2004 (Attorney Docket KLYCF-07001US0);
- U.S. Provisional Patent Application No. 60/523,604 entitled INTEVERTEBRAL BODY FUSION CAGE WITH KEELS AND LATERAL IMPLANTATION METHOD, by Zucherman et al., filed Nov. 20, 2003 (Attorney Docket KLYCF-07000US0).
- This invention relates to an intervertebral body fusion cage.
- The spinal column is a biomechanical structure composed primarily of ligaments, muscles, vertebrae, and intervertebral disks. The biomechanical functions of the spine include: (1) support of the body, which involves the transfer of the weight and the bending movements of the head, trunk and arms to the pelvis and legs; (2) complex physiological motion between these parts; and (3) protection of the spinal cord and nerve roots.
- As the present society ages, it is anticipated that there will be an increase in adverse spinal conditions which are characteristic of aging. For example, with aging comes an increase in spinal stenosis (including, but not limited to, central canal and lateral stenosis), and facet joint degeneration. In addition to spinal stenosis and facet joint degeneration, the incidence of damage to the intervertebral disks is also common.
- The primary purpose of the intervertebral disk is to act as a shock absorber. The disk is constructed of an inner gel-like structure, the nucleus pulposus (the nucleus), and an outer rigid structure comprised of collagen fibers, the annulus fibrosus (the annulus). At birth, the disk is 80% water, but the water content gradually diminishes with time, causing the disk to stiffen. With age, disks may degenerate and bulge, thin, herniate, or ossify. Damage to disks also may occur as a result of disease, trauma, or injury to the spine.
- Disk damage can have far-reaching consequences. By way of example only, both the cervical and lumbar areas of the human spine are, in a healthy state, normally lordotic such that they are curved convex forward. It is not uncommon that in degenerative conditions of the spine, normal curvature is lost. Loss of normal curvature effectively shortens the spinal canal, and decreases its capacity. Further, the absence or loss of normal curvature of the spine moves the spinal cord to a more anterior position, potentially resulting in compression of the posterior portions of the vertebral bodies and the disks. Loss of normal curvature thus disturbs the overall mechanics of the spine, which may cause cascading degenerative changes throughout the adjacent spinal segments.
- The surgical treatment of those degenerative conditions of the spine in which the spinal disks are in various states of collapse commonly involves spinal fusion, that is, the joining together of adjacent vertebrae through an area of shared bone. When the shared bone is in the area previously occupied by the intervertebral disk, the fusion is referred to as an “interbody fusion.” Fusion results in formation of a solid bony mass between adjacent vertebral bodies. The newly formed bony mass can assume a weight-bearing function and thereby relieve mechanical pain caused by an unstable degenerative disk. The bony fusion mass further can prevent long-term disk collapse or additional degenerative changes.
- Fusion can be accomplished by interbody bone grafting. Typically, grafting requires penetrating the vertebral endplates, which are made of hard bone, to prepare the target vertebrae. Such preparation exposes the spongy, vascular, cancellous bone. Bone grafts then are positioned to be in contact with the cancellous bone and the blood supply. The direct contact between the natural or synthetic bone fragments, with or without other bone growth-promoting materials such as growth factors, initiates a controlled healing process, which results in production of new bone and healing of the graft to both opposed vertebral surfaces. The final result is a single, continuous segment of bone that is composed of the new bony mass between, and fused with, two contiguous vertebrae. Fusion is expected to have a higher probability of success with more direct and extensive contact between the bone graft-promoting materials and the cancellous bone.
- Since fusion takes place over time, the spine can remain unstable until fusion is complete. However, spinal instability may contribute to the failure of the fusion. Therefore, a fusion implant is needed that (1) maximizes the probability of success of bone fusion; (2) provides instant stability to the spine while fusion occurs; and (3) is easily implantable and minimizes trauma to the patient and the possibility of surgical and post-surgical complications.
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FIG. 1 . is a perspective view of an embodiment of the disclosed implant of the invention. -
FIG. 2 is a side view of an embodiment of the disclosed implant of the invention ofFIG. 1 . -
FIG. 3 is a cross-sectional view of the embodiment of the disclosed implant of the invention depicted inFIG. 1 . -
FIG. 3A is a view similar toFIG. 3 of an alternative embodiment of the implant of the invention. -
FIG. 3B is a view similar toFIG. 3 of an alternative embodiment of the implant of the invention. -
FIG. 4 is a perspective view of a further embodiment of the disclosed implant of the invention. -
FIG. 5 is a side view of the embodiment of the disclosed implant depicted inFIG. 4 . -
FIG. 6 is a cross-sectional view of the embodiment of the disclosed implant depicted inFIG. 4 . -
FIG. 7 is a cross-sectional view of a further embodiment of the disclosed implant of the invention. -
FIG. 8 is a perspective view of a further embodiment of the disclosed implant of the invention. -
FIG. 9 is a side view of the embodiment of the disclosed implant depicted inFIG. 8 . -
FIG. 10 is a cross-sectional view of the embodiment of the disclosed implant depicted inFIG. 8 . -
FIG. 11 is a perspective view of a further embodiment of the disclosed implant. -
FIG. 12 is a side view of the embodiment of the disclosed implant of the invention depicted inFIG. 11 . -
FIG. 13 is a cross-sectional view of the embodiment of the disclosed implant depicted inFIG. 11 . -
FIG. 14 is a perspective view of a further embodiment of the disclosed implant of the invention. -
FIG. 15 is side view of the embodiment of the disclosed implant depicted inFIG. 14 . -
FIG. 16 is a cross-sectional view of the embodiment of the disclosed implant depicted inFIG. 14 . -
FIG. 17 is a perspective view of a further embodiment of the disclosed implant of the invention. -
FIG. 18 is a side view of the embodiment of the disclosed implant depicted inFIG. 17 . -
FIG. 19 is a cross-sectional view of the embodiment of the disclosed implant depicted inFIG. 17 . -
FIG. 20 is a block diagram showing the method steps of the invention for the lateral implantation of an embodiment of the disclosed the implant of the invention. -
FIG. 21 is a top view of an embodiment of a disclosed keel-receiving channel cutting tool. -
FIG. 22 is a side view of the embodiment of the disclosed keel-receiving channel cutting tool depicted inFIG. 20 . -
FIG. 23 is a distal end view of the embodiment of the disclosed keel-receiving channel cutting tool depicted inFIG. 20 . -
FIG. 24 is a side view of an embodiment of a disclosed implantation tool. -
FIG. 25 is a top view of the embodiment of the disclosed implantation tool depictedFIG. 24 . -
FIG. 26 is a front view of the embodiment of the disclosed implantation tool depicted inFIG. 24 . -
FIG. 27 is a top view of the embodiment of the disclosed implantation tool depicted inFIG. 24 , as it engages an embodiment of the disclosed implant of the invention. -
FIG. 28 is a perspective view of a further embodiment of the disclosed implant of the invention. -
FIG. 29 is a side view of the embodiment of the disclosed implant of the invention shown inFIG. 28 . -
FIG. 30 is a top view of the embodiment of the disclosed implant depicted inFIG. 28 . -
FIG. 31 is a perspective view of an embodiment of the disclosed implant of the invention. -
FIG. 32 is a side view of the embodiment of the disclosed implant of the invention depicted inFIG. 31 . -
FIG. 33 is a is a top view of the embodiment of the disclosed implant depicted inFIG. 31 . - The following description is presented to enable any person skilled in the art to make and use what is disclosed. Various modifications to the embodiments described will be readily apparent to those skilled in the art, and the principles defined herein can be applied to other embodiments and applications without departing from the spirit and scope of what is disclosed and defined by the appended claims. Thus, what is disclosed is not intended to be limited to the embodiments shown, but is to be accorded the widest scope consistent with the principles and features disclosed herein. To the extent necessary to achieve a complete understanding of what is disclosed herein, the specification and drawings of all patents and patent applications cited in this application are incorporated herein by reference.
- Unless otherwise stated, each of the embodiments of the implant of the invention described herein can be implanted from a lateral approach, and also from a posterior or anterior approach, using the appropriate surgical technique.
-
FIGS. 1-3 depict oneembodiment 100 of the disclosed implant. The implant is a fusion cage, adapted to stabilize the affected spine immediately, once anchored in keel-receiving channels cut into the cancellous bone of adjacent vertebral bodies, and to promote bony fusion between the adjacent vertebrae. - This
embodiment 100 of the disclosed implant includes acylindrical cage 10 with ahollow interior 14. Thehollow interior 14 is adapted to contain a graft of bone growth-promoting material, to initiate formation of a bony fusion mass between two affected vertebrae. The bone growth-promoting material can include, but is not limited to, naturally occurring bone, bone chips, processed bone, synthetic bone, hydroxyapatite, calcium phosphate compounds, naturally occurring bone morphogenic proteins, natural, synthetic, and recombinant bone morphogenic proteins, growth factors, and cytokines. - The
hollow interior 14 and the graft materials contained therein are in communication with the exterior of the cage (i.e., the intervertebral space, the vertebral endplates, and the cancellous bone of the affected vertebrae) through a plurality ofapertures 16 configured over the surface of thecage 10 that fully penetrate the surface. It is to be understood that theapertures 16 are to be shaped, sized, and configured over the surface so as to optimize bony ingrowth without compromising the strength of thecage 10. In addition to, or in place of apertures, the surfaces of thecage 10 can be roughened and/or covered with bone growth promoting substances to induce and promote bone growth and integration of thecage 10 into the adjacent vertebrae. The surfaces of thecage 10 further can have a plurality of projections orteeth 28 oriented to further guard against backward expulsion of theimplant 100 from the intervertebral space. - The
cylindrical cage 10 has asuperior surface 18 that abuts the upper vertebra of the two affected vertebrae, and aninferior surface 20 that abuts the lower vertebra. In thisembodiment 100, afirst keel 22, preferably substantially perpendicular to the sagittal plane of the body, extends along thelongitudinal axis 12 of thecylindrical cage 10, and into the cancellous bone of the vertebral body of the top vertebra through a keel-receiving channel cut into the vertebral body of the top vertebra. Similarly, asecond keel 24, preferably substantially perpendicular to the sagittal plane of the body, extends along thelongitudinal axis 12 of thecylindrical cage 10, and into the cancellous bone of the vertebral body of the bottom vertebra through a keel-receiving channel cut into the vertebral body of the bottom vertebra. The keels includeapertures 17 that allow the patient's vertebral bone to grow through to further stabilize and integrate theimplant 100 into the upper and lower vertebral bodies that are to fused together. - The keels 22, 24 serve to stabilize the affected spine immediately upon implantation. Further, because they extend beyond the vertebral endplate and into the cancellous bone of the vertebral body, the
keels implant 100. In addition to theapertures 17, thekeels implant 100 can be so treated. The keels 22, 24 therefore not only stabilize the spine, but also serve to enhance bone growth and fusion of the affected contiguous vertebrae. - It is to be understood that the
keels longitudinal axis 12 of thecylindrical cage 10. Moreover, although thisembodiment 100 of the disclosed implant only has twokeels longitudinal axis 12 of the cage, as described herein below, or along parallel longitudinal axes. - As depicted in
FIGS. 3A and 3 b the keels can have different configurations. InFIG. 3A theimplant 100 includes a plurality ofkeels 22 extending from thesuperior surface 18 and a plurality ofkeels 24 extending from theinferior surface 20. Overall, thekeels teeth 28 andapertures 17 as described above, in the context of describing the other keels. These keels also can be roughened and/or covered with bone growth-promoting substances. Such additional keels may allow for stabilization of the implant into the adjacent vertebral bodies. - It is further within the scope of this disclosure for the
keels extension 36 from the end of the keel that is distal to thecage 10. Theextension 36 can be substantially perpendicular to avertical axis 26 of thekeels extension 36 creates a keel that has a “T” shape, or an inverted “T”-shape, depending upon the surface of the cage from which thekeel vertical axis 26 of thekeel keels FIG. 3B , theimplant 100 includeskeels - Each
keel teeth 28 extending from the end of the keel distal to thecage 10, and from the top of theextension 36. Anyprojections 28 are oriented at an angle that will guard against backward expulsion of theimplant 100 from the intervertebral space. - It is within the scope of this disclosure for the
cage 10 to have a taperedfirst end 32 of thecylindrical cage 10, that serves as the leadingend 32. The tapered leadingend 32 may facilitate insertion of the implant between the two affected vertebrae, while the vertebrae are distracted apart, if necessary, to accommodate theimplant 100. The tapered leadingend 32 can be closed, to retain the graft materials remain inside thecage 10. Thecage 10 further can be sealed at asecond end 34, which is the trailing end, and also the end of thecage 10 through which the graft material is received into thehollow interior 14. A cap, not shown, can be used to seal thesecond end 34. - The
second end 34 also can be adapted operably to connect with a surgical instrument for implantation, not shown. By way of example only, the second/trailingend 34 can have at least onehole 31 adapted to receive at least one pin extending from a first end of a surgical implantation instrument. The hole/pin combination operably connects the implant with the implantation tool, and the latter is used to position the implant within the intervertebral space. Positioning the implant will include aligning at least one keel with a keel-receiving channel cut into at least one vertebrae. The implantation step would occur after first exposing the target contiguous vertebrae; removing the affected disk if necessary; distracting the target vertebrae, if necessary; creating keel-receiving channels in the vertebral bodies; and filling the implant with the graft materials, either prior to of after the implant is inserted between the vertebral bodies. As the implant preferably is inserted laterally, along a line that is preferably substantially perpendicular to the sagittal plane of the patient's body, the keels also enter laterally and can add stability in the sagittal plane, the plane where flexion and extension occurs. This method is described in greater detail below. - The
cylindrical cage 10 can be made from a variety of materials, including but not limited to bioceramics; calcium phosphate ceramics, such as hydroxyapatite tricalcium phosphate, tetracalcium phosphate, α-calcium pyrophosphate, β-calcium pyrophosphate and mixtures thereof; and ceramic/growth factor composites, such as ceramic/bone morphogenic protein (“BMP”) composite (made with any BMP, whether natural, synthetic, or recombinant). The implant also can be made of medical grade titanium, stainless steel or cobalt chrome. Other materials that have appropriate structural strength and that are suitable for implantation into a patient can also be used. - One other class of materials contemplated for use is the class of biocompatible polymers. Copolymers, blends and composites of polymers are also contemplated for fabrication of parts of the disclosed device. A copolymer is a polymer derived from more than one species of monomer. A polymer composite is a heterogeneous combination of two or more materials, wherein the constituents are not miscible, and therefore exhibit an interface between one another. A polymer blend is a macroscopically homogeneous mixture of two or more different species of polymer.
- One group of biocompatible polymers is the polyaryl ester ketones which has several members, which include polyetheretherketone (PEEK), and polyetherketoneketone (PEKK). PEEK has proven as a durable material for implants, as well as meeting criteria of biocompatibility. Medical grade PEEK is available from Victrex Corporation under the product name PEEK-OPTIMA. Medical grade PEKK is available from Oxford Performance Materials under the name OXPEKK, and also from CoorsTek under the name BioPEKK. Still another interesting group of biocompatible polymers is the polyalkyl biocompatible polymers, such as polyethylenes, polypropylenes, and the like.
- These medical grade biocompatible polymers also are available as reinforced polymer materials. To reinforce a polymeric material, fillers are added to a polymer, copolymer, polymer blend, or polymer composite. Fillers are added to modify properties, such as mechanical, optical, and thermal properties. In this case, fillers, such as carbon fibers, are added to reinforce the polymers mechanically to enhance strength for certain uses, such as load bearing devices.
-
FIGS. 4-6 depict anembodiment 200 of the disclosed implant having acage 210 with a cubical configuration. The cubical configuration can enhance the communication of the bone graft and bone growth-promoting contents contained in thehollow interior 214 of thecubical cage 210 by bringing a greater surface area of thecage 210, and hence, a greater amount of bone graft material, into direct contact with the cancellous bone of the vertebral bodies. Further the flat superior 218 and inferior 220 planar surfaces of thecage 210 create stabilizing surfaces that mate with the upper and lower end plates of the upper and lower vertebrae. It is to be understood that, for all embodiments, the vertebrae may be somewhat shaped in order to accept the superior 218 and inferior 220 planar surfaces of thecage 210. - As with the embodiments previously described, a plurality of
keels cage 210 of the implant. Thekeels teeth 228 to guard against expulsion backward from the direction of insertion, and a plurality ofapertures 217. - The
cage 210 has ahollow interior 214 as above, that is in communication with the exterior of the cage via a plurality ofapertures 216 that fully penetrate the surface of thecage 210. Theembodiment 200 further can have a taperedleading end 232, and an open trailing end 234 for receiving at least one type of bone growth-promoting materials. As with all of the embodiments described herein, the surfaces of thecage 210 can be roughened and/or covered with bone growth promoting substances and/or have apertures in order to induce bone growth and integration of thecage 210 into the adjacent vertebrae. Further, as with all of the embodiments,implant 200 can be made of any one or any combination of materials as described above and can be packed with any one or any combination of the bone growth-promoting substances described herein. -
FIG. 7 depicts a further embodiment of the disclosed implant having two keels 322 on the superior surface 318 of thecage 310, and two keels 324 on the inferior surface 320 of acubical cage 310. It is further within the scope of this disclosure to have a plurality of keels 322, 324 on the superior 318 and inferior 320 surfaces of thecage 310 irrespective of the shape of the cage. The keels 322, 324 further can have an extension (not shown) substantially perpendicular to the vertical axis 326 of the keel, extending from the end of the keel distal to thecage 310. The keels 322, 324 can extend the full length of the longitudinal axis of thecage 310. Alternatively, the keels 322, 324 can be shorter. Several keels 322, 324 can be aligned along one longitudinal axis, and/or several can be aligned along parallel longitudinal axes. -
FIGS. 8-10 depict afurther embodiment 400 of the disclosed implant. Thisembodiment 400 has a wedge-shape for correcting curvature of the spine. - In a healthy state, the cervical and lumbar spines normally have a lordotic curvature. In degenerative conditions of the spine, normal such normal curvature can be lost. The loss of anatomical curvature effectively shortens the spinal canal and thereby decreases its capacity. The absence of normal curvature also moves the spinal cord so that it becomes compressed against the posterior sections of the vertebral bodies and disks. Loss of anatomical curvature disturbs the overall mechanics of the spine, and the disruption may cause cascading degenerative changes throughout the adjacent spinal segments.
- A wedge-shaped
implant 400 withkeels implants 400 that can return the anatomical curvature to the spine, while also promoting bone fusion as described for the other embodiments above. Theseembodiments 400 can haveapertures 416 through the surfaces of the wedge-shapedcage 410, and/or roughened surfaces, and/or bone growth-promoting substances on their surfaces to induce and promote bone ingrowth and fuse the affected vertebrae. They also can haveapertures 417 through thekeels cage 410. Thekeels teeth 428 to protect against expulsion of the implant. - The
cage 410 is wedge-shaped in a plane that is perpendicular to thelongitudinal axis 412 of thecage 410. The narrowest 438 and the widest 440 surfaces of the wedge-shapedcage 410 run parallel to the longitudinal axis of thecage 412 and are opposite each other, rather than adjacent surfaces. Such implants can be manufactured so that a given wedge-shapedcage 410 has an angular dimension that can be custom-selected for a patient's specific needs and anatomy. Moreover, thekeels - It should be appreciated that
embodiment 400 also can be implanted from an anterior or posterior approach. Either of those approaches would correct lateral curvature of the spine. -
FIGS. 11-13 depict afurther embodiment 500 of the disclosed implant. Thisembodiment 500 is similar to theembodiment 400 inFIGS. 8-10 , with the difference being that the narrowest 538 and widest 540 surfaces ofembodiment 500 are arranged opposite to their respective positions inembodiment 400. Likeembodiment 400,embodiment 500 can be implanted laterally to restore normal curvature to the spine; alternatively, if implanted from an anterior or posterior approach,embodiment 500 would correct lateral curvature of the spine. - As discussed above, scoliosis, or abnormal lateral curvature of the spine, can also be corrected by positioning a wedge-shaped implant with keels in the intervertebral space. The implant can be constructed for different angles of correction, as with the implant for correcting loss of normal curvature.
FIGS. 14-16 depict anembodiment 600 of the disclosed invention that is wedge-shaped for correcting scoliosis, or abnormal lateral curvature, when implanted from a lateral approach. Rather than having narrowest and widest surfaces parallel to the longitudinal axis of the cage, the cage instead is wider at the trailingend 634 of thecage 610 and narrower at the taperedleading end 632. Thecage 610 thus is wedge-shaped in a plane that is parallel to the longitudinal axis ofembodiment 600. It should be understood that if theembodiment 600 is implanted from a posterior or anterior approach, it would correct loss of lordotic curvature of the spine, rather than correct abnormal lateral curvature. - As with the other embodiments already disclosed and described, the
cage 610 includes ahollow interior 614. Thehollow interior 614 is adapted to receive and contain any one or combination of the bone growth-promoting materials and substances described above. - Also with the other embodiments, the
cage 610 can be roughened and/or covered with bone growth-promoting substances. The surfaces of thecage 610 alternatively can have a plurality ofapertures 616. Either measure alone, or both in combination, induce bone growth and integration of thecage 610 into the adjacent vertebrae to be fused. - The
implant 610 has at least onekeel 622 on thesuperior surface 618 of thecage 610, and at least onekeel 624 on theinferior surface 620 of thecage 610. Thekeels cage 610, can also have a plurality ofapertures 617. Thekeels cage 610 can be made of any one or any combination of the materials as described above. They further can have projections orteeth 628 that are oriented to prevent backward expulsion of the implant from the intervertebral space. Moreover, as with the other embodiments, thekeels implant 600. Instead, they can be shorter. There can be a plurality ofkeels FIG. 3A . In addition, or in the alternative, thekeels FIG. 3B . All of thekeels implant 600 in the cancellous bone of the vertebral bodies. As such, thekeels -
FIGS. 17-19 depict anembodiment 700 of the disclosed invention that also is wedge-shaped, for correction of scoliosis.Embodiment 700 is different fromembodiment 600, since thecage 710 ofembodiment 700 is intended to correct the opposite lateral curvature. However, it should be understood that, as withembodiment 600, implantation ofembodiment 700 from a posterior or anterior approach could be used to restore normal lordotic curvature to the spine. - The
cage 710 can be a wedge-shape with rounded edges, as if formed from a cage shaped like a cylinder, or with corners, as if formed from a cage shaped like a rectangular box. As in all of the other embodiments described herein, the cage includes ahollow interior 714 adapted to hold bone growth-promoting materials that encourage bony ingrowth from the vertebral bodies through the cage. Thehollow interior 714 can be packed with any one or any combination of the bone growth-promoting substances described herein above. - Also as with other embodiments described herein, the
cage 710 can have at least one keel, said keel to have a plurality ofapertures 717. Thekeels cage 710, can run the entire longitudinal length of thecage 710, or they can be shorter. They also can be arrayed in a star-like pattern, as depicted inFIG. 3A . Alternatively or additionally, thekeels cage 710 that makes the keel T-shaped or cross-shaped in cross-section substantially perpendicular to the vertical axis of the keel. This embodiment is depicted inFIG. 3B . - The
cage 710 and keels 722, 724 as with all of the embodiments described herein, can be made of any one or any combination of materials described above. Thecage 710 and keels 722, 724 can be roughened and/or haveapertures 716 and/or be covered or coated with bone growth-inducing substances to induce bone growth and integration of thecage 710 into the adjacent vertebrae to stabilize the affected spine. -
FIG. 20 is a block diagram showing the basic steps of the disclosed method of the invention of laterally inserting the disclosed implant of the invention in the spine. However, it should be noted at the outset that all embodiments of the disclosed implant can be implanted not only from a lateral approach, but also from either an anterior or posterior approach, using the appropriate surgical technique and instruments. Preferably the embodiments ofFIGS. 17-19 are inserted with a posterior approach or an anterior approach. The anterior and posterior approaches are well-known. - First, 810 the spine is exposed through a lateral access. However, it is also within the scope of the disclosed method to access the spine from an anterior or
posterior approach 815, using an appropriate well-known technique. Next, the affected intervertebral disk is removed if necessary 820, and the two vertebrae to be fused are distracted apart, if necessary 830. As before, it is also contemplated that these steps can occur from a posterior or anterior approach. - Keel-receiving channels next are cut into at least one of the affected vertebrae, using a wedge- or chisel-shaped surgical instrument adapted to penetrate the cortical bone and into the cancellous bone of the
vertebral bodies 840. The number of keel-receiving channels to be cut and their position will be determined by the number and configuration of the keels on the selected embodiment of the disclosed implant. It may also be necessary to use an appropriate surgical tool to shape the vertebral bones to accommodate theimplant 850. - Either before or after the implant is inserted between the vertebral bodies, bone and/or bone growth-promoting materials are packed into the hollow interior of the implant through the open second end of the cage that is the trailing end, distal to the tapered
leading end 860. The implant then is sealed 870 at its trailing end. A cap can be used to close off the trailing end, and the trailingend 880 or thecap 885 can be adapted operably to associate with a surgical instrument that can be used to guide the implant into the intervertebral space. While the implant is guided into position, the keels are aligned with the keel-receiving channels cut into thevertebral bodies 880. Once the implant is properly positioned and the procedure is complete, the surgical incision is closed. - Additional steps, such as additional distraction from different approaches, can also be performed without departing from the scope of what is disclosed. It is to be understood that any of the embodiments can be inserted laterally, that is substantially perpendicularly to the sagittal plane of the patient. The implants also can be inserted along a posterior/anterior line, with some implants preferably inserted from the posterior and some inserted from an anterior direction. For example, the implants of
FIGS. 1-13 preferably are inserted from a lateral direction. The implants depicted inFIGS. 14-16 are preferably inserted from a posterior direction.FIGS. 17-19 are preferably inserted from an anterior direction. - In addition to disclosure of embodiments of a fusion implant, tools for preparing and inserting an implant are also disclosed.
FIGS. 21-23 show an embodiment of a tool for preparing vertebral bodies to receive any of the implants discussed above, whileFIGS. 24-27 show an embodiment of an implantation tool for inserting embodiments of the disclosed implants. -
FIGS. 21-23 are the top view, the side view, and an end view of the keel-receivingchannel cutting tool 900. Thecutting tool 900 has ahandle 910 at its proximal end for controlling the tool during operation. As will be appreciated by those of skill in the art, thehandle 910 can be removable or affixed to the cutting end. Thedistal end 902 of thetool 900 is a solid head that has anupper surface 905, and alower surface 906. Theupper surface 905 has afirst blade 912 mounted thereon, and thelower surface 906 has asecond blade 914 mounted thereon. Preferably thefirst blade 912 is about centered with theupper surface 905, and thesecond blade 914 is about centered with thelower surface 906. The first andsecond blades FIG. 23 is a view of the distal end of thecutting tool 900 showing thebeveled end 916 and the first andsecond blades head 902 of the cutting tool 900 (shown inFIG. 23 ) approximates the distance between two vertebral bodies or the height of the disk space. In this embodiment of cuttingtool 900, theblades head 902. - As will be appreciated by those of skill in the art, the tool shown in
FIG. 21 can be modified such that instead of cutting keel-receiving channels in the upper and lower vertebral bodies at the same time, two tools are provided so that only one vertebral body is cut for keel-receiving channels at a time. For example, an alternative embodiment of cuttingtool 900 has a first tool with a single blade mounted on thehead 902. A second tool could be provided having a single blade mounted on thehead 902, and additionally on the opposing surface, a guide. The guide on the surface opposite the surface with the blade is designed to engage with the first keel-receiving channel cut the first vertebrae with the first tool to ensure that the second cut is optimally aligned with the first cut. - It is to be further appreciated by those of skill in the art that the
blades FIG. 3B . It is further to be understood that theblades FIG. 3A . Other arrays of theblades -
FIGS. 24-27 depict the implanting tool used to insert an implant, such as those embodiments disclosed herein, between vertebral bodies.FIG. 24 is a side view of theimplantation tool 1000 that has ahandle 1010 and animplant holder 1020. Theimplant holder 1020 has animplant contacting surface 1024 and at least onepin 1022, shown inFIG. 25 , for engaging the trailing end of an implant. The contactingsurface 1024 can be shaped to conform to any shape given to the trailing end of the implant. The implant nests within a contactingsurface 1024 and is held bypins 1022.FIG. 26 shows the distal view of the end of the tool with twopins 1022 for securing the implant.FIG. 27 shows how thepins 1022 would engage the trailing end of an implant, such asimplant 100 depicted inFIG. 3 . - A variety of kits can be assembled that include an implant selected for a particular patient. The kit could also include
several cutting tools 900 and several implantingtools 1000 or a single handle that cooperates with cutting ends 902 and implantation ends 1020. -
FIGS. 28-30 depict afurther embodiment 1100 of the disclosed implant, which is intended to be implanted from a lateral surgical approach between adjacent vertebral bodies that are to be fused. -
Embodiment 1100 has acage 1110 that is D-shaped from a top-view of theimplant 1100, as depicted inFIG. 30 . The curved side orsegment 1101 of the D-shape is the side of theimplant 1100 that will be oriented anteriorly, during lateral implantation and once implanted, because thecurved segment 1101 corresponds to the rounded anterior side of the vertebral body. The substantially straight segment of the D-shape 1103 is located at the opposite and posterior side of theimplant 1100. - The
implant 1100 has a leading end 1132 and a trailing end 1134. The leading end 1132 is the first part of theimplant 1100 to be inserted into the intervertebral space, and is oriented so that thecurved side 1101 of the D-shape of theimplant 1100 corresponds to the curved anterior of the vertebral bodies when theimplant 1100 is positioned. For ease of insertion, the leading end 1132 can be tapered. - The
cage 1110 has at least one keel that stabilizes the affected spine upon implantation and thus increases the likelihood of a successful fusion. Each keel fits into a keel-receiving channel that is cut through the vertebral bone endplate and into the cancellous bone of the vertebral body, exposing the cancellous bone. Exposing the cancellous bone puts this tissue in communication with bone growth-promoting materials inside thecage 1110, as explained further below, which promotes bone fusion. - In a preferred embodiment, the
first keel 1122 extends from asuperior surface 1118 of thecage 1110, whichsuperior surface 1118 faces the upper vertebra of the vertebrae to be fused, and asecond keel 1124 extends from aninferior surface 1120 of thecage 1110, whichinferior surface 1120 faces the lower of the two vertebrae to be fused. Thelongitudinal axis 1109 of thekeels axis 1108 drawn from the anterior end of the implant 1100 (i.e., the end that contains the curved side of the D-shape 1101) to the posterior end of the implant 1100 (i.e., the end that contains the substantially straight side of the D-shape 1103). Accordingly, as theimplant 1100 is implanted, thekeels longitudinal axis 1109. Thelongitudinal axis 1109 of thekeels - In a preferred embodiment, the
keels axis 1108 running from the anterior and posterior ends of theimplant 1100. The T-shape can contribute further to the stability of the affected spine by providing additional surface area upon which the cancellous bone can rest. It should be appreciated by one skilled in the art that there can be a plurality of keels which can be variously arrayed or configured over the superior 1118 and inferior 1120 surfaces of thecage 1110. The keels further can have a plurality of apertures 1117 (not shown) to promote bony ingrowth. - The
cage 1110 has a hollow interior 1114 adapted to contain at least one bone growth-promoting material. Thehollow interior 1114 is adapted to contain a bone graft or other bone growth-promoting material, to initiate formation of a bony fusion mass between two affected vertebrae. The bone growth-promoting materials can include, but are not limited to, naturally occurring bone, bone chips, processed bone, synthetic bone, hydroxyapatite, calcium phosphate compounds, naturally occurring bone morphogenic proteins, natural, synthetic, and recombinant bone morphogenic proteins, growth factors, and cytokines. Thehollow interior 1114 of thecage 1110 is in communication with the exterior of thecage 1110, where the cancellous bone of the vertebral bodies has been exposed, through a plurality ofapertures 1116 that fully penetrate the surface of the cage. - In a preferred embodiment, the superior 1118 and inferior 1120 surfaces of the
cage 1110 are substantially open to hollow interior 1114 because theapertures 1116 on either side of thekeels keels cage 1110 to abut the vertebral bodies and brings the bone growth-promoting materials in thehollow interior 1114 of thecage 1110 into direct and intimate contact with the exposed cancellous bone. Theapertures 1116 in the superior 1118 and inferior 1120 surfaces of thecage 1110 need not be capped because they abut the vertebral bodies. Moreover, theimplant 1100 is made of materials that resist compression, as described further below, and therefore compressive forces on the spine will not cause exudation or migration of the bone growth-promoting materials from the hollow interior 1114 through thoseapertures 1116. - In a preferred embodiment,
additional apertures 1116 are configured on the leading 1132 and trailing 1134 ends. Theapertures 1116 on the trailing end 1134 can be used to pack thehollow interior 1114 of theimplant 1100 with at least one bone-growth promoting material during implantation surgery. Alternatively, the hollow interior 1114 can be pre-packed before surgery. Theseapertures 1116 can be sealed with a cap (not shown) or also left open. - The superior 1118 and inferior 1120 surfaces of the
cage 1110 can have a plurality of projections orteeth 1128 that can penetrate the vertebral endplates. The projections orteeth 1128 are oriented to prevent posterior expulsion of theimplant 1100 from the intervertebral space. The projections orteeth 1128 can penetrate at least partially the vertebral endplate and thus can enhance anchoring of the implant to prevent expulsion. - The projections or
teeth 1128 also can serve a dual function. By engaging the vertebral bones, the projections orteeth 1128 can further enhance bone healing and bony fusion of the vertebral bodies. Thus, by exposing fresh bone of the vertebral bodies, the penetration of the vertebral bones by the projections orteeth 1128 can further stimulate bone healing, in addition to the healing reaction set in motion by cutting keel-receiving channels and providing bone growth-promoting materials in thehollow interior 1114 of thecage 1110. - The
cage 1110 also can have at least one hole (not shown) in the trailing end 1134, adapted to receive a mating pin component extending from a surgical implantation tool. The pin and the hole can be paired operably to connect the implant with the implantation tool. The tool with the connected implant then is used to position the implant between the vertebral bodies that are to be stabilized through implantation surgery and fused. - It should be appreciated that the shape of the
cage 1110 can be varied either to correct for loss of normal lordotic curvature of the spine, or to correct for scoliosis (excessive lateral curvature of the spine). Thecage 1110 can be wedge-shaped, to correct scoliosis, with the wedge being narrower at the leading end 1132 and broader at the trailing end 1134. Theimplant 1100 can be implanted from either side of the patient to correct scoliosis. The appropriate side depends upon the lateral curvature that is to be corrected while accomplishing interbody fusion. - Alternatively, the
cage 1110 can be wedge-shaped in a manner that will correct loss of normal lordotic curvature. To restore normal curvature, the wedge of thecage 1110 would be oriented in a plane that is parallel to theaxis 1108 between the anterior and posterior sides of theimplant 1100. - The
implant 1100 can be made from a variety of materials, including but not limited to bioceramics; calcium phosphate ceramics, such as hydroxyapatite tricalcium phosphate, tetracalcium phosphate, α-calcium pyrophosphate, β-calcium pyrophosphate and mixtures thereof; and ceramic/growth factor composites, such as ceramic/bone morphogenic protein (“BMP”) composite (made with any BMP, whether natural, synthetic, or recombinant). The implant also can be made of medical grade titanium, stainless steel or cobalt chrome. Other materials that have appropriate structural strength and that are suitable for implantation into a patient can also be used. - One other class of materials contemplated for use is the class of biocompatible polymers. Copolymers, blends and composites of polymers are also contemplated for fabrication of parts of the disclosed device. A copolymer is a polymer derived from more than one species of monomer. A polymer composite is a heterogeneous combination of two or more materials, wherein the constituents are not miscible, and therefore exhibit an interface between one another. A polymer blend is a macroscopically homogeneous mixture of two or more different species of polymer.
- One group of biocompatible polymers is the polyaryl ester ketones which has several members, which include polyetheretherketone (PEEK), and polyetherketoneketone (PEKK). PEEK has proven as a durable material for implants, as well as meeting criteria of biocompatibility. Medical grade PEEK is available from Victrex Corporation under the product name PEEK-OPTIMA. Medical grade PEKK is available from Oxford Performance Materials under the name OXPEKK, and also from CoorsTek under the name BioPEKK. Still another interesting group of biocompatible polymers is the polyalkyl biocompatible polymers, such as polyethylenes, polypropylenes, and the like.
- These medical grade biocompatible polymers also are available as reinforced polymer materials. To reinforce a polymeric material, fillers are added to a polymer, copolymer, polymer blend, or polymer composite. Fillers are added to modify properties, such as mechanical, optical, and thermal properties. In this case, fillers, such as carbon fibers, are added to reinforce the polymers mechanically to enhance strength for certain uses, such as load bearing devices.
-
FIGS. 31-33 depict afurther embodiment 1200 of the disclosed implant of the invention. Thisembodiment 1200 is for implantation from an anterior surgical approach. Accordingly, the posterior end of the implant is theleading end 1232, or the end that is first inserted into the intervertebral space, and the anterior end of the implant is the trailingend 1234. - Similar to
cage 1110,cage 1210 is D-shaped from a top view (FIG. 33 ). The side that is curved like the curved side of the D-shape 1201 is the trailing/anterior end 1234 of theimplant 1200 that will be positioned anteriorly in the patient's body when implanted from an anterior approach. The substantially straight side of the D-shape 1203 corresponds to the leading/posterior end 1232 of theimplant 1200 that will be positioned posteriorly in the patient's body when implanted from an anterior approach. For ease of insertion, theleading end 1232 can be tapered. - The
cage 1210 has at least one keel, like thecage 1110. As discussed above, each keel is received into a keel-receiving channel cut with a “T”-shaped cutter into the cancellous bone of a vertebral body during surgery with a keel-receiving channel cutting tool. In a preferred embodiment having twokeels first keel 1222 extends from thesuperior surface 1218 of thecage 1210, and asecond keel 1224 extends from theinferior surface 1220 of thecage 1210. Thelongitudinal axis 1209 of thekeels axis 1108 extending from the anterior/trailingend 1234 to the posterior/leading end 1132 of theimplant 1200. In other words, thekeels end 1234 to the posterior/leadingend 1232 of theimplant 1200. Accordingly, when theimplant 1200 is inserted during surgery, thekeels longitudinal axis 1209 of thekeels end 1232 and the anterior/trailingend 1234. - It should be appreciated that for
implants implant 1100, theimplant 1200 can have keels that are configured in different ways over the surface(s) of theimplant 1200. - A preferred embodiment has
keels longitudinal axis 1209 of thekeels - The
cage 1210 has a hollow interior 1214 that is adapted to contain at least one of the bone growth-promoting materials set forth above. Thehollow interior 1214 is in communication with the exterior of thecage 1210 through a plurality ofapertures 1216 that fully penetrate the surface of thecage 1210. In a preferred embodiment, the superior 1218 and inferior 1220 surfaces of thecage 1210 are substantially open to the hollow interior 1214 because theapertures 1216 on either side of thekeels keels cage 1210 to abut the vertebral bodies and brings the bone growth-promoting materials in the hollow interior 1214 into direct and intimate contact with the exposed cancellous bone. Theapertures 1216 in the superior 1218 and inferior 1220 surfaces of thecage 1210 need not be capped because they abut the vertebral bodies. Moreover, theimplant 1200 is made of materials discussed above that resist compression, and therefore protect the materials in the hollow interior 1214 from expulsion from theimplant 1200. - In a preferred embodiment,
additional apertures 1216 are configured on the trailingend 1234.Apertures 1216 also can be located on theleading end 1232. The trailingend apertures 1216 can be used to pack bone growth-promoting materials into the hollow interior 1214 during surgery, particularly after theimplant 1200 is positioned. Alternatively, thehollow interior 1214 of theimplant 1200 can be pre-packed and implanted. Theapertures 1216 can be sealed with a cap (not shown) or also left open. - The superior 1218 and inferior 1220 surfaces of the
cage 1210 can have a plurality of projections orteeth 1228 that can penetrate the vertebral endplates and that are oriented to prevent backward expulsion of the implant. As discussed above, the projections orteeth 1228 further promote bony fusion. - As above for
implant 1100, the trailingend 1234 ofimplant 1200 can have at least one hole adapted to mate with at least one pin on an implantation tool. The tool is thus operably connected with theimplant 1200 and used to position theimplant 1200 in the intervertebral space during implantation surgery. - As discussed above, the shape of the
cage 1210 can be varied to correct for loss of lordotic curvature or to correct lateral curvature of the spine. To correct lateral curvature of the spine, thecage 1210 can be wedge-shaped with the wedge oriented in a direction perpendicular to thelongitudinal axis 1209 of thekeels axis 1208 between the anterior/trailingend 1234 and posterior/leadingend 1232. To correct loss of normal curvature of the spine, the wedge can be oriented in a direction parallel toaxis 1208 andaxis 1209. - The cage can be made of any of the materials discussed at length above for
embodiment 1100. - What has been disclosed herein has been provided for the purposes of illustration and description. It is not intended to be exhaustive or to limit what is disclosed to the precise forms described. Many modifications and variations will be apparent to the practitioner skilled in the art. What is disclosed was chosen and described in order to best explain the principles and practical application of the embodiments described herein, thereby enabling others skilled in the art to understand the various embodiments and various modifications that are suited to the particular use contemplated. It is intended that the scope of what is disclosed be defined by the following claims and their equivalence.
Claims (26)
1-42. (canceled)
43. An intervertebral spinal fusion implant comprising:
a D-shaped body including a peripheral wall that encloses an inner cavity, said peripheral wall having a D-shaped cross-section and including a curved anterior end and an opposite posterior end with an anterior-posterior axis drawn from said curved anterior end to said posterior end, said body having superior and inferior sides with said superior side adapted to engage an upper vertebral body and said inferior side adapted to engage a lower vertebral body, said superior and inferior sides each including an opening communicating with said inner cavity;
a rib extending across said inner cavity and including a first end joined to said peripheral wall adjacent said curved anterior end and a second end joined to said peripheral wall adjacent said posterior end; and
a first keel extending from said rib in a superior direction, a second keel extending from said rib in an inferior direction, and wherein each of said keels extends along a longitudinal axis substantially parallel to said anterior-posterior axis.
44. The implant of claim 43 wherein said peripheral wall further includes opposite sides extending generally parallel with one another along said anterior-posterior axis from said curved anterior end to said posterior end.
45. The implant of claim 44 wherein said opposite sides are planar.
46. The implant of claim 43 wherein each of said keels has a T-shaped cross section.
47. The implant of claim 43 wherein each of said keels extends from an exterior of said peripheral wall at said curved anterior end to an exterior of said peripheral wall at said posterior end.
48. The implant of claim 43 wherein each of said keels extends along an entire outer dimension of said body along said anterior-posterior axis.
49. The implant of claim 43 wherein said keels are formed integral with said rib to define a single, unitary piece of said body.
50. The implant of claim 43 wherein said superior and inferior sides taper relative to one another to provide said body with a wedge shape.
51. The implant of claim 50 wherein said superior and inferior sides taper relative to one another along said anterior-posterior axis to provide said body with said wedge shape.
52. The implant of claim 51 wherein said superior and inferior sides taper along an entire dimension of said body from said curved anterior end to said posterior end.
53. The implant of claim 50 wherein said superior and inferior sides taper relative to one another in a direction generally perpendicular to said anterior-posterior axis to provide said body with said wedge shape.
54. The implant of claim 50 wherein said superior and inferior sides are substantially planar.
55. The implant of claim 50 wherein said body tapers from a narrower end at one of said anterior and posterior ends to a broader end at the other of said anterior and posterior ends.
56. The implant of claim 55 wherein said body is narrower at said anterior end and broader at said posterior end.
57. The implant of claim 43 wherein said superior and inferior sides each define a plurality of teeth.
58. The implant of claim 43 wherein said peripheral wall defines a plurality of apertures communicating with said inner cavity to place said inner cavity in communication with an exterior of said body.
59. The implant of claim 58 wherein at least one of said apertures is positioned on each side of said first and second keels.
60. The implant of claim 43 further comprising a bone growth promoting material positioned within said inner cavity, said bone growth promoting material selected from the group of materials consisting of naturally occurring bone, processed bone, synthetic bone, hydroxyapatite, calcium phosphate compounds, naturally occurring bone morphogenic proteins, recombinant bone morphogenic proteins, synthetic bone morphogenic proteins, growth factors, and cytokines.
61. The implant of claim 43 wherein said body is formed of a material selected from the group consisting of bioceramics, calcium phosphate ceramics, chrome cobalt, titanium, stainless steel, biocompatible carbon fiber reinforced polymer, biocompatible polymers, copolymers, and blends and composites of polymers.
62. The implant of claim 61 wherein said body is comprised of a biocompatible polymer including polyaryl ester ketone.
63. An intervertebral spinal fusion implant comprising:
a D-shaped body including a peripheral wall that encloses an inner cavity, said peripheral wall having a D-shaped cross-section and including a curved anterior end and an opposite posterior end with an anterior-posterior axis drawn from said curved anterior end to said posterior end, said body having superior and inferior sides with said superior side adapted to engage an upper vertebral body and said inferior side adapted to engage a lower vertebral body, said superior and inferior sides each including an opening communicating with said inner cavity;
a rib extending across said inner cavity and including a first end joined to said peripheral wall adjacent said curved anterior end and a second end joined to said peripheral wall adjacent said posterior end; and
a first keel extending from said rib in a superior direction, a second keel extending from said rib in an inferior direction, and wherein each of said keels has a T-shaped cross section extending along a longitudinal axis substantially parallel to said anterior-posterior axis, and wherein said keels are formed integral with said rib.
64. The implant of claim 63 wherein said peripheral wall further includes opposite planar sides extending generally parallel with one another along said anterior-posterior axis from said curved anterior end to said posterior end.
65. The implant of claim 63 wherein each of said keels extends along an entire outer dimension of said body along said anterior-posterior axis from an exterior of said peripheral wall at said curved anterior end to an exterior of said peripheral wall at said posterior end.
66. The implant of claim 63 wherein said superior and inferior sides taper relative to one another to provide said body with a wedge shape.
67. The implant of claim 66 wherein said superior and inferior sides taper relative to one another along said anterior-posterior axis to provide said body with said wedge shape.
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US7837732B2 (en) | 2010-11-23 |
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